An Approval and an Inventive Step in Alzheimer’s Disease.
SPECIAL REPORT An Approval and an Inventive Step in Alzheimer’s Disease.
Regulation
FDA, EMA, approvals, compliance, regulatory affairs
Alzheimer’s Disease Conundrum
The following article and its associated commentary were published in the February 2023 edition of MedNous.
The Alzheimer’s puzzle isn’t yet solved.
Commentary The Alzheimer’s puzzle isn’t yet solved.
US FDA approves Lecanemab for the treatment of Alzheimer’s disease.
SPECIAL REPORT #23.2 US FDA approves Lecanemab for the treatment of Alzheimer’s disease.
US Congressional report faults FDA and Biogen for Alzheimer’s drug approval
SPECIAL REPORT #22.12.5
US Congressional report faults FDA and Biogen for Alzheimer’s drug approval
You will find below the Executive Summary of the US Congressional Report on the Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans prepared by the Staffs of the
The FDA grants an accelerated approval for Biogen’s aducanumab for the treatment of Alzheimer’s disease
SPECIAL REPORT #21.17 The FDA grants an accelerated approval for Biogen’s aducanumab for the treatment of Alzheimer’s disease The U. S.
Neuroscience: the poor cousin of drug discovery
This article was published in a slightly revised form in the February 2019 issue of MedNous
Aging populations everywhere are on the rise creating a need for new medicines to treat neurological disorders. However recent data from the US Food and Drug Administration suggests that this need is not being